Microvascular and Metabolic Effects of High-intensity Interval Exercise Training (HIIT-FAST)
Microvascular and Metabolic Effects of High-intensity Interval Training (HIIT) and Intermittent Fasting (FAST) in Overweight or Obese, Sedentary Women With Cardiometabolic Risk Factors: HIIT-FAST, a Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. Increases of physical activity and modifications of eating behaviors are first-line interventions which, however, are not easily implemented, and lack of time to exercise and difficulties in coping with different diets are common reasons for failure. High-intensity interval training (HIIT) is a "faster" alternative to moderate-intensity continuous training (CT). Conversely, intermittent fasting is also an alternative to more complex diets, as it restricts caloric intake to a specified period of time without major diet composition changes. The combination of HIIT and fasting may therefore provide incremental benefits.
Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before the initiation of the interventions and 4 weeks thereafter.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Rio de Janeiro, Brasil, 22240-006
- National Institute of Cardiology, Ministry of Health, Brazil
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female gender
- Age≥ 30 years and ≤50 years
- Premenopausal status
- Body mass index >25 kg/m2
- At least one of the following:
waist circumference ≥80 cm (women); triglycerides ≥150 mg/dl or treatment for this lipid abnormality; High density-lipoprotein cholesterol <50 mg/dl (women), or treatment for this abnormality; fasting plasma glucose ≥100 mg/dl
Exclusion Criteria:
- Any cardiovascular disease, including systemic hypertension
- Diabetes mellitus
- Chronic pulmonary disease
- Any systemic disease or condition that might reduce the adherence or tolerance to exercise or fasting
- Orthopedic or neurologic conditions that might impair exercise training
- Pregnancy or breastfeeding
- Abnormalities elicited at exercise treadmill testing that preclude the initiation of exercise training
- Current engagement in any exercise training protocol
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: HIIT only
Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state
|
High-intensity interval exercise training in the fed state
|
|
Experimental: CT+FAST
Volunteers will be submitted to continous training (CT) performed in the fasting state
|
Continous exercise training in the fasting state
|
|
Experimental: CT only
Volunteers will be submitted to continous training (CT) performed in fed state.
|
Continous exercise training in the fed state
|
|
Experimental: HIIT+FAST
Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.
|
High-intensity interval exercise training in the fasting state
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Capillary density
Periodo de tiempo: 6 months
|
Number of spontaneously perfused skin capillaries per mm2
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Microvascular reactivity assessed by laser speckle contrast imaging
Periodo de tiempo: 6 months
|
Skin microvascular flow in arbitrary perfusion units
|
6 months
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: EDUARDO V TIBIRICA, MD, PhD, National Innstitute of Cardiology
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CAAE:69240017.1.0000.5272
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .